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Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT04850937
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Ma Hong, Yangzhou University

Brief Summary:

esketamine is an optical isomer of ketamine. Compared with ketamine, esketamine has the characteristics of higher effective value, stronger receptor affinity, less adverse reactions of nervous system, and pharmacokinetics is controllable.

Domestic and foreign studies have focused on the therapeutic effect of esketamine on major depression, but less attention has been paid to perioperative depression.This study intends to explore the effect of small doses of esketamine on patients with breast cancer.Postoperative depression and pain are observed.


Condition or disease Intervention/treatment Phase
Depression Drug: Esketamine Drug: normal saline Not Applicable

Detailed Description:

This study intends to explore the effect of small doses of esketamine on patients with breast cancer.WE pay attention to :

  1. Safety of low-dose single intravenous injection of esketamine (1)The influence of intraoperative vital signs of patients after medication, such as blood pressure and heart rate fluctuation; (2)the duration of recovery after anesthesia; (3)postoperative adverse reactions, such as nausea and vomiting, dizziness and diplopia, respiratory depression, laryngeal spasm, delirium agitation, etc
  2. Effect of single intravenous injection of low-dose ketamine on postoperative depression in patients undergoing radical mastectomy (1) 1 day before surgery, 2 days, 5 days, 30 days, 90 days after surgery Hamilton Depression Scale scores; (2) The serum leptin level 1 day before surgery, 2 days after surgery and 5 days after surgery; (3) Correlation between depression scale score and leptin level
  3. Effects of low dose esketamine on acute and chronic pain in patients undergoing radical mastectomy

    • visual analogue scale scores at 6, 12 and 24 hours after surgery;

      • visual analogue scale scores at 3, 5, 30 and 90 days after surgery;

        • the number of analgesic remedies

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 180 patients will be divided into two groups according to the random number table method: control group (normal saline group),treatment group (esketamine group), 120 cases in each group.
Masking: Double (Participant, Investigator)
Masking Description:

esketamine 10ml (5mg/ml) and normal saline 10ml were respectively set as drug A or drug B.

Without the knowledge of the experimenter, the predetermined dose of drug A or B will be given to the experimenter before induction of anesthesia, with 0.05 mL /kg for each patient.

After all samples are collected, the third party will announce the grouping and medication.

Primary Purpose: Prevention
Official Title: Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer
Actual Study Start Date : February 10, 2021
Actual Primary Completion Date : April 10, 2021
Estimated Study Completion Date : May 10, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Esketamine

Arm Intervention/treatment
Experimental: Group S
The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction During administration, blood pressure and heart rate were observed.
Drug: Esketamine
The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction

Placebo Comparator: Group C
The control group will receive the same amount of normal saline after anesthesia induction
Drug: normal saline
The experimental group will be given 0.5ml/kg normal saline intravenously after anesthesia induction




Primary Outcome Measures :
  1. depression score [ Time Frame: Change from Baseline score at 3 months ]

    The total rough score is the sum of all the scores in the 20 items, and then the rough score is multiplied by 1.25 to take the round part to get the standard score.

    An SDS score of 53 to 62 is classified as mild depression, 63 to 72 as moderate depression, and 73 or more as major depression.



Secondary Outcome Measures :
  1. pain score [ Time Frame: Change from Baseline score at 3 months ]

    visual analogue scale 0 points painless;

    1 to 3 points for mild pain; 4 to 6 points moderate pain; Severe pain on a 7-9 scale; 10 points severe pain.


  2. The serum leptin level [ Time Frame: Change from 1 day before surgery to 90 days after surgery ]
    The serum leptin level 1 day before surgery, 2 days ,5 days 30 days and 90 days after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) Female patients who planned to undergo unilateral modified radical mastectomy in breast surgery; (2)Years of education ≥5 years,American Society of Anesthesiologists Ⅰ-II grade; (3) All patients undergoing surgery within 1 week after diagnosis of breast cancer, and do not receive preoperative radiotherapy or chemotherapy; (4) All the patients were married and had children, and were mainly cared for by their immediate family members after surgery.

Exclusion Criteria:

  • (1) Antidepressant treatment was received within the last 2 months; (2) previous personality disorder, intellectual retardation, brain injury or brain disease, combined with schizophrenia, mania and other mental diseases; (3) Preoperative patients with hyperthyroidism or hypothyroidism, severe cardiovascular disease, diabetes, severe blood deficiency, and abnormal heart, lung, liver, and kidney functions; (4) with diseases of the immune system, or use drugs that have obvious effects on the immune system; (5) Pregnancy or lactation;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04850937


Contacts
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Contact: MA HONG 13675161040 mahongyzdaxue@163.com
Contact: LIU M YU 17625860820 myliu@yzu.edu.cn

Locations
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China, Jiangsu
Affiliated hospital of yangzhou university Recruiting
Yangzhou, Jiangsu, China, 225100
Contact: Ma Hong    13675161040    mahongyzdaxue@163.com   
Sponsors and Collaborators
Yangzhou University
Investigators
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Principal Investigator: LIU M YU Yangzhou University
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Responsible Party: Ma Hong, Department of Anesthesiology, Yangzhou University Affiliated Hospital, Yangzhou University
ClinicalTrials.gov Identifier: NCT04850937    
Other Study ID Numbers: ES
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ma Hong, Yangzhou University:
Esketamine
Depression
pain
leptin
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Esketamine
Antidepressive Agents
Psychotropic Drugs